US10966793B2 - Device for positioning sterile instruments - Google Patents

Device for positioning sterile instruments Download PDF

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Publication number
US10966793B2
US10966793B2 US15/571,643 US201615571643A US10966793B2 US 10966793 B2 US10966793 B2 US 10966793B2 US 201615571643 A US201615571643 A US 201615571643A US 10966793 B2 US10966793 B2 US 10966793B2
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Prior art keywords
sheath
instrument
sterile
gas
membrane
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US15/571,643
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US20180303569A1 (en
Inventor
Michael Vogele
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ISYS Medizintechnik GmbH
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ISYS Medizintechnik GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A61B46/10—Surgical drapes specially adapted for instruments, e.g. microscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A61B46/20—Surgical drapes specially adapted for patients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/40—Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3407—Needle locating or guiding means using mechanical guide means including a base for support on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3409—Needle locating or guiding means using mechanical guide means including needle or instrument drives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A61B46/20—Surgical drapes specially adapted for patients
    • A61B2046/205—Adhesive drapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments

Definitions

  • the invention relates to a device for positioning of sterile instruments according to the preamble of claim 1 , in particular for controlled movement thereof in a robot-assisted surgical procedure at a sterile area around an interventional site.
  • a sterile atmosphere around the treated body or skin area of the patient is of great importance to prevent infection. For this reason, in hospitals, and especially in the treatment rooms, a high standard of sterility must be ensured, which applies to the patient, the treating staff and the instruments or devices used. Especially with minimal or micro-invasive procedures, such as percutaneous needle puncture, the surgically treated body surface is very small and sometimes even limited to the respective puncture point. Sterility is also required with multiple needle or instrument placement, especially in the environment of the resulting skin puncture.
  • a remote-controlled robot In a variety of surgical procedures, the use of a remote-controlled robot is advantageous.
  • surgery robots are often used in conjunction with devices that use electromagnetic radiation to determine the precise puncture position on the patient and the correct penetration depth, f. i. by using X-ray devices.
  • X-ray devices In view of dangerous X-rays, treatment persons exposed to radiation are even risking health. Further, the spatial constriction by the X-ray device makes a manual intervention on the patient difficult.
  • robots and micromanipulators are far superior to the human hand as to high-precision instrument positioning in 3D space. For these and other reasons, robots and remote manipulators are increasingly used e.g.
  • Surgical robots that allow the introduction and manipulation of needles and needle-like (micro) instruments as well as therapeutic and diagnostic (micro) apparatus are suitable for use with imaging techniques (such as CT, C-bow, X-ray, MRI, ultrasound etc.) by the relatively small size of the robots to be suitably used at narrow sites to be treated.
  • imaging techniques such as CT, C-bow, X-ray, MRI, ultrasound etc.
  • the distance between the holders of the robot to the needle should be as short as possible, but this carries the risk of contamination of the resulting puncture by the robot.
  • WO 2010/121107 A1 discloses a surgical manipulator which is packaged as a whole in a sterile packaging (similarly also in U.S. Pat. No. 6,132,368) and the robot can be controlled in a wireless way.
  • the surgical tool is attached to the outside of the sterile packaging of the manipulator.
  • This arrangement allows for a high degree of sterility of the manipulator, but has the disadvantages of using electromagnetic radiation to manipulate the instrument and placing the surgical tool outside of the sterile package around the manipulator.
  • the basic idea of the invention is that a cover or sheath from the environment (incl. robot) sterilizes the surgical tool and the device is designed to maintain the sterile atmosphere in a limited volume around the surgical site. This arrangement allows for a sterile atmosphere, locally at the intervention site, that is not affected by the surgical procedure and the cleanliness conditions outside of the array.
  • the proposed device is used for positioning, in particular the introduction and manipulation of needles and (micro) instruments and the positioning of therapeutic and diagnostic (micro) apparatus, such as puncture, injection, ablation needles or endoscopes or the like to a patient.
  • the “balloon-like” sheath is sterile at least on its inner side and surrounds a sterile instrument at least partially, preferably completely or mostly.
  • at least one gas-tight passage is provided at the sheath, which can serve for coupling an instrument holder.
  • the instrument holder like the instrument itself, is received in a sterile manner in the envelope-like sheath and can be moved in at least two spatial directions in a controlled manner by movement of the instrument holder outside the sheath.
  • the instrument holder preferably has coupling parts (quick-release fasteners) outside of the sleeve-like sheath to an external manipulator, which may be formed according to the above-cited state of the art, in particular according to EP 1 722 698 B1.
  • the components of the device may be sterilized in common or separately by known sterilization procedures and can be safely stored in a sterile packaging or transport box.
  • the assembly of the individual components can take place in a sterile environment before the sterilization procedure or directly before the procedure in a sterile environment.
  • the sterile instrument preferably has at least one needle-shaped tip with which a membrane directed towards the patient can be perforated.
  • the instrument tip can be fitted with a cap, which can be pushed-off via the sheath before intervention.
  • the attachment of the sheath on the patient, more precisely at the point of intervention is preferably performed with an adhesive surface.
  • the site of intervention is locally cleaned prior to surgery, to increase sterility or to complete the cleaning process at the site, wherein the adhesive surface may be provided with antiviral, antibacterial coating.
  • the adhesive surface may be reinforced by mechanical structures and may have grip-like protuberances.
  • the sterile instrument held in the shell can also be controlled by a finger or handle, especially for short procedures without prolonged exposure to radiation or when using imaging techniques without radiation exposure (such as ultrasound or MRI).
  • the handle in particular at the end opposite the tip, can be arranged outside the sleeve, whereas the main part of the instrument projects into the sheath through a passage. This design is suitable when the sterile instrument is closed at the front end or is a hollow needle, which has a sterile connection to the outside of the sheath for supplying substances in the hollow needle.
  • a membrane is provided in the device, which encloses the instrument at the puncture site in a gas-tight manner.
  • the outside of the membrane is covered by at least one peelable protective film, wherein the membrane and/or protective film can be stabilized by a retaining ring, as described above.
  • active or passive markers may be attached to all components of the device.
  • the sheath preferably includes an inlet valve, which serves to supply sterilizing gas and/or inert gas into the sheath, preferably for generating an overpressure within the sheath, which has a vent for free movement of the “inflated” sheath.
  • the inlet valve or semi-permeable membrane can simultaneously serve as a pressure relief valve or outlet valve when placing the instrument.
  • FIG. 1 an overview of the device
  • FIG. 2 an enlarged perspective view analogous to FIG. 1 ;
  • FIG. 3 a further enlargement according to FIGS. 1 and 2 ;
  • FIG. 4 a transport container for this purpose.
  • a device 1 as described above is placed on a body part of a patient, e.g. on a spine or a knee joint.
  • a sterile instrument 2 for example a puncture needle or injection needle, is attached by means of a likewise sterile holder 2 ′ in a sheath 3 , which is sterile at least on its inner side.
  • the sheath 3 is preferably transparent in the manner of a balloon. Gas-tight passages 4 in the sheath 3 connect the sterile instrument holder 2 ′ to coupling parts 5 , at which a surgical robot or manipulator 1 ′ can be attached by suitable connections.
  • the operative tool (instrument 2 ) within the sterile interior of the sheath 3 can be moved from its outside.
  • a membrane 6 may be provided, which can be pierced by the tip 2 a (after penetrating or removing a tip protector).
  • the membrane 6 is gas-tightly attached to the sheath 3 , similar to the passages 4 .
  • a reinforcing or retaining ring 7 for stabilization is further attached to the sheath 3 around the membrane 6 and is fixed to the previously disinfected puncture site of the patient P with a bonding surface 7 ′, shown here in dotted manner.
  • At least one peelable protective film 8 protects the membrane 6 from possible contamination before use.
  • a gas-tight sleeve 9 is provided as a passage through which the instrument 2 can protrude to the outer space of the sheath 3 .
  • the top end of the needle may be provided with a hand or finger grip 2 b to move the needle, if necessary, manually and sensitively.
  • a port 11 at the top of the instrument 2 allows drug delivery through a hollow needle to the patient.
  • the protruding part of the needle can also be provided with a dome part in order to carry out a robot-controlled movement of the needle, namely an axial feed movement.
  • FIG. 3 shows such coupling members 5 in the form of jack plugs.
  • an inlet valve 12 (optionally provided with a filter) may be used for supplying a suitable gas in the sheath 3 to generate a slight overpressure therein, which prevents ingress of germs from outside air during treatment.
  • a suitable gas for example, purified air or pure nitrogen may be used.
  • a further opening 13 may be provided at the shell or sheath 3 , via which the supplied gas escapes from the sheath 3 , for example, if the shell is stabilized by the gas pressure in such a strong way that free movement of the needle 2 relative to the sheath 3 or to the membrane 6 becomes difficult.
  • Disinfections before and after the use of the device 1 can be made by supplying a disinfecting gas through the valve 12 .
  • a disinfecting gas instead of a valve, semi-permeable shell materials can be used, which allow an inflow or outflow of gases.
  • gas sterilization gas-free sterilization processes (e.g. irradiation) may be used.
  • the entire device 1 (with sheath 3 , instrument 2 , etc.) can also be sterilized via the valve 12 and then packaged in a transport container 10 .
  • the components are kept sterile for later intervention on the patient.
  • the device also allows robot-assisted procedures on a patient in a sterile room created locally around the skin puncture of the patient.
  • the treatment robot, other instruments and persons in the treatment room do not come in contact with the patient and the disinfected needle in contact with the air. This ensures that any problems of sterility in the treatment room have little or no effect on the sterility at the localized treatment point.
  • this device enables the implementation of sterile (micro) invasive procedures, even in non-sterile environments. Especially in countries where there no sterile operating rooms and surgery conditions exist due to lack of money, a multitude of interventions under highest sterility standards becomes possible. Even in richer countries, high hygienic standards in many medical fields are hardly affordable. In particular, in image-based operations many premises do not meet the required hygienic standards. As a result, many rooms either have to be extensively and costly rehabilitated or may no longer be used for (image-based) (robotic) interventions. The proposed device efficiently solves all of these problems in an inexpensive way.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Surgical Instruments (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Manipulator (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
US15/571,643 2015-05-03 2016-05-03 Device for positioning sterile instruments Active 2037-07-27 US10966793B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE202015003206.0U DE202015003206U1 (de) 2015-05-03 2015-05-03 Vorrichtung zur Positionierung von sterilen lnstrumenten
DE202015003206.0 2015-05-03
PCT/EP2016/000722 WO2016177463A1 (de) 2015-05-03 2016-05-03 Vorrichtung zur positionierung von sterilen instrumenten

Publications (2)

Publication Number Publication Date
US20180303569A1 US20180303569A1 (en) 2018-10-25
US10966793B2 true US10966793B2 (en) 2021-04-06

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US15/571,643 Active 2037-07-27 US10966793B2 (en) 2015-05-03 2016-05-03 Device for positioning sterile instruments

Country Status (5)

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US (1) US10966793B2 (de)
EP (1) EP3291757B1 (de)
DE (1) DE202015003206U1 (de)
ES (1) ES2754578T3 (de)
WO (1) WO2016177463A1 (de)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10933223B2 (en) 2016-09-30 2021-03-02 Boston Scientific Scimed, Inc. Access devices and associated methods
US20210015564A1 (en) * 2018-04-13 2021-01-21 Isys Medizintechnik Gmbh Medical Robot
CN112972018A (zh) * 2021-02-02 2021-06-18 于乐泳 一种心血管介入局部保护装置

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0516582A1 (de) 1991-05-27 1992-12-02 SULZER Medizinaltechnik AG Punktiergerät für Blutgefässe
DE4403567A1 (de) 1994-02-07 1995-08-10 Storz Karl Gmbh & Co Vorrichtung zur Durchführung endoskopischer Operationen mittels einer intra- und/oder extrakorporalen Hülle
US20050101868A1 (en) 2003-11-11 2005-05-12 Ridley Stephen F. Ultrasound guided probe device and method of using same
DE102009019695A1 (de) 2009-05-05 2010-11-25 Deutsches Zentrum für Luft- und Raumfahrt e.V. Steriles Abdecksystem zum sterilen Verkleiden eines medizintechnischen Roboterarms sowie Verfahren zum sterilen Verkleiden eines medizintechnischen Roboterarms
DE202012002296U1 (de) 2012-03-10 2013-03-11 Isys Medizintechnik Gmbh Vorrichtung zum Nadelvorschub
US20140166023A1 (en) 2011-08-04 2014-06-19 Olympus Corporation Operation support device and assembly method thereof
WO2014162217A1 (en) 2013-04-05 2014-10-09 Sofar S.P.A. Surgical system with sterile wrappings

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US5176689A (en) 1988-12-23 1993-01-05 Medical Instrumentation And Diagnostics Corporation Three-dimensional beam localization apparatus for stereotactic diagnoses or surgery
US7699855B2 (en) 1996-12-12 2010-04-20 Intuitive Surgical Operations, Inc. Sterile surgical adaptor
US6132368A (en) 1996-12-12 2000-10-17 Intuitive Surgical, Inc. Multi-component telepresence system and method
DE202004003646U1 (de) 2004-03-06 2005-09-01 Medical Intelligence Medizintechnik Gmbh Vorrichtung zur Ansteuerung körperlicher Strukturen
DE102006004703B4 (de) * 2006-01-31 2016-08-04 MedCom Gesellschaft für medizinische Bildverarbeitung mbH Verfahren und Anordnung zum Betreiben eines Positionierungsroboters
US20100268250A1 (en) 2009-04-17 2010-10-21 Microdexterity Systems, Inc. Surgical system with medical manipulator and sterile barrier
DE202011109495U1 (de) * 2011-12-27 2013-01-08 Isys Medizintechnik Gmbh Nadelführung
DE102013002813B4 (de) 2013-02-19 2017-11-09 Rg Mechatronics Gmbh Haltevorrichtung mit wenigstens einer Klemmbacke für ein chirurgisches Robotersystem

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0516582A1 (de) 1991-05-27 1992-12-02 SULZER Medizinaltechnik AG Punktiergerät für Blutgefässe
DE4403567A1 (de) 1994-02-07 1995-08-10 Storz Karl Gmbh & Co Vorrichtung zur Durchführung endoskopischer Operationen mittels einer intra- und/oder extrakorporalen Hülle
US20050101868A1 (en) 2003-11-11 2005-05-12 Ridley Stephen F. Ultrasound guided probe device and method of using same
DE102009019695A1 (de) 2009-05-05 2010-11-25 Deutsches Zentrum für Luft- und Raumfahrt e.V. Steriles Abdecksystem zum sterilen Verkleiden eines medizintechnischen Roboterarms sowie Verfahren zum sterilen Verkleiden eines medizintechnischen Roboterarms
US20140166023A1 (en) 2011-08-04 2014-06-19 Olympus Corporation Operation support device and assembly method thereof
DE202012002296U1 (de) 2012-03-10 2013-03-11 Isys Medizintechnik Gmbh Vorrichtung zum Nadelvorschub
WO2014162217A1 (en) 2013-04-05 2014-10-09 Sofar S.P.A. Surgical system with sterile wrappings
US20160058513A1 (en) * 2013-04-05 2016-03-03 Sofar S.P.A. Surgical system with sterile wrappings

Non-Patent Citations (1)

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Title
International Search Report (ISR) with patent family annex dated Jul. 14, 2016 for PCT/EP2016/000722.

Also Published As

Publication number Publication date
EP3291757A1 (de) 2018-03-14
WO2016177463A1 (de) 2016-11-10
US20180303569A1 (en) 2018-10-25
DE202015003206U1 (de) 2016-05-10
ES2754578T3 (es) 2020-04-20
EP3291757B1 (de) 2019-09-25

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